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Australian Export Controls and the Life Sciences

A guide to understanding export control laws regarding the physical export, intangible supply, publication or brokering of life sciences related goods, software or technology

5: Exemptions (decontrols) to software and technology controls

There are several overarching exemptions which decontrol some “software” and “technology” that would otherwise be subject to export control. In Part 1 of the DSGL, the technology exemptions are written as Notes against Item ML22. In Part 2 of the DSGL, there are two General Notes that apply to all software and technology controls, being the General Technology Note and the General Software Note.

These notes exempt from export controls:

  • Software and technology that is already “in the public domain”;
  • Technology that is “basic scientific research”;
  • Software and technology that is the minimum necessary information for patent applications;
  • Software that is mass-marketed; or
  • Medical equipment that incorporates controlled software.

5.1: Information in the public domain

A permit is not required for information that is in the public domain. Information in the public domain can be:

  • published technical papers;
  • publications such as books, journals and newspapers that are available from stores or libraries that are accessible to the public;
  • subscriptions which are available to any individual who desires to obtain or purchase the published information;
  • unlimited distribution at a conference, seminar, trade show or exhibition;
  • general information for marketing purposes such as product brochures and company presentations (if it contains intellectual property then it may be controlled technology, but company literature that is in the public domain will not be controlled); or
  • information provided by a patent office without restriction in support of a domestic patent application; or
  • information on general scientific principles that are commonly taught in schools, colleges and universities.

5.2: Basic Scientific Research

Basic scientific research” is defined in the DSGL as experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental principles of phenomena or observable facts, not primarily directed towards a specific practical aim or objective.  

There are two approaches which may help to determine if research fits within this exemption – the use of the Australian Bureau of Statistics research definitions, or the use of Technology Readiness Levels (TRLs).

One approach is to assess if the Research meets the criteria of the Australian Bureau of Statistics definitions as being either pure basic research or strategic basic research. Research that meets either of these definitions will fall within the threshold of “basic scientific research” and will therefore be exempt from permit requirements. In addition, any technology that is derived from that research activity is also not subject to export controls.

The Australian Bureau of Statistics definitions are as follows:

  • Pure basic research is experimental and theoretical work undertaken to acquire new knowledge without looking for long term benefits other than the advancement of knowledge, and
  • Strategic basic research is experimental and theoretical work undertaken to acquire new knowledge directed into specified broad areas in the expectation of useful discoveries. It provides the broad base of knowledge necessary for the solution of recognised practical problems.

An alternative approach is the assessment of the maturity of the technology being researched using Technology Readiness Levels (TRLs). Technology Readiness Levels is a methodology that is used to determine the maturity of technology as it moves through its lifecycle from research and development through to production and deployment. Technology Readiness Levels are based on a scale from 1 to 9 with 9 being the most mature technology.

In the context of the life sciences, research and technology that is at levels 1 or 2 will not require a permit. As the technology reaches levels 3 or 4 in its maturity, a permit may be required but an assessment should be conducted to confirm that view. Technology at levels 5 and above will usually have met the threshold of being technology “required” for the “development” or “production” or “use” of a ‘DSGL-listed item’. Unless an exemption applies, technology at these levels will require an export permit.

A table describing the Technology Readiness Levels in more detail is at Annex 3.

5.3: Minimum necessary information for patent applications

This exemption applies to the export or supply of ‘DSGL technology’ for the purpose of seeking a patent in Australia or overseas. Seeking a patent includes lodging a patent application and the supply of ‘DSGL technology’ to a person or organisation (e.g. a Patent Office, patent attorney, research collaborator or a patent review panel) that is directly associated with the lodging (or potential lodging) of a patent application, or as a result of the patent examination process.

Supply for a purpose that is not directly related to seeking a patent will require a permit (unless other exemptions apply); for example, the supply of ‘DSGL technology’ to a research collaborator located overseas before a decision is made to seek a patent.

Once a provisional patent application is filed, any supplies of ‘DSGL technology’ to further develop an invention prior to preparing/submitting a complete patent application will require a permit. The supply of ‘DSGL technology’ for the purpose of locating investors and determining overseas markets (including forwarding a recently-filed provisional application) will require a permit.

The process of publishing a patent (or an unsuccessful application) into the public domain is covered by this exemption. Until such time as that information exists in the public domain, it is still controlled and would require a permit to be supplied if it is not for the purpose of seeking a patent and no other exemptions apply.

5.4: Medical equipment

A permit is not required for Part 2 (Dual-use) ‘DSGL-listed items’ when such items are incorporated into equipment that has been specially designed for medical end-use. Specially designed for medical end-use means that the equipment is designed for medical treatment or the practise of medicine, but it does not include equipment for medical research.

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